Harmony Biosciences Holdings Inc. has announced a settlement agreement with Lupin Limited, resolving patent infringement litigation over Lupin's attempt to produce a generic version of WAKIX® (pitolisant hydrochloride). Under the agreement, Lupin will be able to launch its generic product no earlier than January 2030, or potentially in July 2030 with pediatric exclusivity. Additionally, the U.S. Patent Office Patent Trial and Appeal Board recently upheld the validity of Harmony's exclusively licensed polymorph patent for pitolisant hydrochloride by declining to initiate an Ex Parte Reexamination. Harmony continues to defend its intellectual property, reinforcing its patent portfolio's strength, which protects its innovations in sleep/wake therapeutics.
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